Positive proof-of-concept clinical data show substantial improvements in visual acuity in

概念验证临床试验的阳性数据显示，视力显著改善

limbal stem cell deficiency (

角膜缘干细胞缺乏症（

LSCD) patients treated with CSB-001

接受CSB-001治疗的LSCD患者

Pivotal studies for CSB-001 in LSCD planned for 1H 2027

CSB-001 治疗角膜缘干细胞缺乏症（LSCD）的关键性研究计划于 2027 年上半年进行

Series B funds Claris through pivotal development and supports pre-commercialization activities

B轮融资助力Claris完成关键开发阶段，并支持其商业化前活动

Stephen Brady appointed President and Chief Executive Officer, Brian Baum named Chief Commercial Officer, and Marc de Garidel appointed Chairman of the Board

斯蒂芬·布雷迪被任命为总裁兼首席执行官，布莱恩·鲍姆被任命为首席商务官，马克·德加里德尔被任命为董事会主席

JERSEY CITY, N.J., July 28, 2026 (GLOBE NEWSWIRE) --

新泽西州泽西市，2026年7月28日（环球新闻社）--

Claris Biotherapeutics, Inc.

Claris Biotherapeutics, Inc.

, a late-stage biopharmaceutical company dedicated to advancing transformative therapies for sight-threatening conditions where limited or no treatment options exist, today announced multiple key milestones, including the close of a $118 million Series B financing and key executive and board appointments.

，一家专注于推进针对威胁视力且治疗选择有限或无治疗选择的疾病进行变革性疗法研发的后期生物制药公司，今日宣布多项重要里程碑，包括完成1.18亿美元的B轮融资以及关键高管和董事会成员的任命。

These catalysts are designed to accelerate the company’s next phase of growth as it advances CSB-001 (oremepermin alfa ophthalmic solution) based on positive proof-of-concept data towards the planned initiation of pivotal studies in 1H 2027 in patients with limbal stem cell deficiency (LSCD), a blinding disease impacting the ocular surface, representing an area of high unmet need where no approved drug therapy exists..

这些催化剂旨在加速公司下一阶段的成长。基于积极的概念验证数据，公司正推进CSB-001（oremepermin alfa滴眼液）的研发，计划于2027年上半年在角膜缘干细胞缺乏症（LSCD）患者中启动关键性研究。LSCD是一种影响眼表、可导致失明的疾病，目前尚无获批的药物治疗，存在巨大的未满足医疗需求。

Financing Details

融资详情

The $118M Series B financing was co-led by new investors Samsara Biocapital and Catalio Capital Management, and joined by Adage Capital Management, Sofinnova Investments, Aisling Capital, and ADAR1 Capital Management, with continued support from all existing investors, Novo Holdings, Janus Henderson Investors, and Mass General Brigham Ventures.

1.18亿美元的B轮融资由新投资者Samsara Biocapital和Catalio Capital Management联合领投，Adage Capital Management、Sofinnova Investments、Aisling Capital和ADAR1 Capital Management参与投资，所有现有投资者Novo Holdings、Janus Henderson Investors和Mass General Brigham Ventures继续提供支持。

Proceeds from the fundraise will be used to complete Claris’ ongoing clinical trials in patients with LSCD, including a proof-of-concept study evaluating CSB-001 and a non-interventional natural history study. The financing will also fund the company through a planned pivotal program of CSB-001 in patients with LSCD, scheduled to start in 1H 2027, and enable pre-commercialization activities.

此次融资所得将用于完成Claris在角膜缘干细胞缺乏症（LSCD）患者中正在进行的临床试验，包括一项评估CSB-001的概念验证研究和一项非干预性自然病程研究。该融资还将支持公司开展计划中的CSB-001在LSCD患者中的关键性注册临床研究项目（预计于2027年上半年启动），并推动上市前准备工作。

CSB-001 targets the underlying pathophysiology of LSCD by promoting corneal epithelial regeneration while modulating inflammation and fibrosis. Clinical data generated to date have demonstrated substantial improvements in visual acuity. Claris expects to report its proof-of-concept results in LSCD during the second half of 2026..

CSB-001 通过促进角膜上皮再生，同时调节炎症和纤维化，针对角膜缘干细胞缺乏症（LSCD）的潜在病理生理机制。迄今为止产生的临床数据已表明视力显著改善。Claris 公司预计将在 2026 年下半年公布其在 LSCD 领域的概念验证结果。

In connection with the financing, Stephen Brady, President and CEO of Claris, Mike Dybbs, Ph.D., Partner at Samsara Biocapital, Matthew Hobson, Ph.D., Principal at Catalio Capital Management, and Maha Radhakrishnan, M.D., Executive Partner at Sofinnova Investments, joined the board of directors.

在此次融资之际，Claris 总裁兼首席执行官 Stephen Brady、Samsara Biocapital 合伙人 Mike Dybbs 博士、Catalio Capital Management 负责人 Matthew Hobson 博士以及 Sofinnova Investments 执行合伙人 Maha Radhakrishnan 医学博士加入了董事会。

Claris Appointments

Claris 预约

Stephen Brady, President & CEO

斯蒂芬·布雷迪，总裁兼首席执行官

, has nearly 30 years of operational, transactional, and board experience spanning corporate strategy, M&A, business development, and finance across public and private life sciences companies. Prior to Claris, Mr. Brady was the Chairman of the Board and CEO of Tempest Therapeutics, and prior to this position, he was executive vice president of strategy and finance at Immune Design and played a key role in the company's IPO, financings, licensing deals, and eventual sale to Merck.

，拥有近30年的运营、交易及董事会经验，涵盖上市和私营生命科学公司的企业战略、并购、业务发展和财务等领域。在加入Claris之前，Brady先生曾担任Tempest Therapeutics的董事会主席兼首席执行官；在此职位之前，他曾任Immune Design的战略与财务执行副总裁，在该公司的首次公开募股（IPO）、融资、许可交易以及最终出售给默克公司的过程中发挥了关键作用。

Earlier in his career, he held progressively senior roles at several biopharmaceutical companies, including vice president of corporate development at Proteolix. In this position, Mr. Brady led Proteolix’s business development and strategic efforts that culminated in the company’s sale to Onyx Pharmaceuticals.

在职业生涯早期，他在多家生物制药公司担任过 progressively 更高级的职务，包括在 Proteolix 担任企业发展副总裁。在该职位上，Brady 先生领导了 Proteolix 的业务发展和战略工作，最终促成了该公司向 Onyx Pharmaceuticals 的出售。

Proteolix’s lead asset, Kyprolis.

Proteolix 的核心资产 Kyprolis。

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®

(carfilzomib), subsequently became the cornerstone of Onyx and a principal driver of Amgen’s $10.4 billion acquisition of Onyx. Mr. Brady currently serves on the Board of Directors of Claris and the Biotechnology Innovation Organization (BIO).

（卡非佐米）随后成为Onyx公司的基石，也是安进公司以104亿美元收购Onyx的主要驱动因素。Brady先生目前担任Claris公司和生物技术创新组织（BIO）的董事会成员。

Brian Baum, CCO,

布莱恩·鲍姆，首席创意官，

brings to Claris more than 20 years of program and lifecycle management, commercial strategy, marketing, market access, commercial operations, and specialty product launch experience in biopharma. Prior to Claris, Mr. Baum served as Senior Vice President at Dompé Pharmaceuticals and led critical commercial initiatives that supported the successful U.S.

为Claris带来了超过20年的生物制药领域的项目与生命周期管理、商业战略、市场营销、市场准入、商业运营以及 specialty 产品上市经验。在加入Claris之前，Baum先生曾担任Dompé Pharmaceuticals的高级副总裁，并领导了支持其在美国成功的关键商业举措。

launch and growth of Oxervate.

Oxervate 的上市与增长。

®

®

, a recombinant human nerve growth factor approved in 2018 for neurotrophic keratitis, a rare and serious eye disease with no prior FDA-approved therapies. As a senior commercial leader, Mr. Baum played a key role in driving Oxervate’s growth, with annual U.S. sales surpassing $1.1 billion in 2024. Prior to Dompé, Mr.

，一种于2018年获批用于治疗神经营养性角膜炎的重组人神经生长因子，该病是一种罕见且严重的眼部疾病，此前尚无美国食品药品监督管理局（FDA）批准的疗法。作为资深商业领袖，鲍姆先生在推动Oxervate增长方面发挥了关键作用，其2024年在美国的年销售额超过11亿美元。在加入Dompé之前，鲍姆先生

Baum spent ten years at Genentech in a range of U.S. and global commercial leadership roles, including supporting the launch and commercialization of Lucentis.

鲍姆在基因泰克公司任职十年，担任过多个美国及全球商业领导职务，其中包括支持Lucentis的上市和商业化。

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®

across three major retinal indications: wAMD, RVO, and DME.

涵盖三大视网膜适应症：湿性年龄相关性黄斑变性（wAMD）、视网膜静脉阻塞（RVO）和糖尿病性黄斑水肿（DME）。

Marc de Garidel, Chairman,

马克·德·加里德尔，董事长，

is a recognized biotech entrepreneur and global pharmaceutical executive with a distinguished track record of building and scaling innovative healthcare companies, advancing breakthrough therapies, and creating substantial shareholder value through organic growth and strategic M&A across the biotechnology sector.

是一位公认的生物科技企业家和全球制药高管，在打造和扩展创新型医疗企业、推动突破性疗法发展，以及通过有机增长和在整个生物科技领域的战略并购创造巨大股东价值方面，拥有卓越的业绩记录。

Since May 2023, Mr. de Garidel has served as CEO of Abivax, leading the development of obefazimod for ulcerative colitis and driving exceptional corporate growth, from a $500 million to a $14 billion company in over three years. Prior to Abivax, he was CEO of CinCor Pharma from 2020 to 2023, where he successfully led the company through its acquisition by AstraZeneca.

自2023年5月以来，德加里德尔先生一直担任Abivax的首席执行官，领导溃疡性结肠炎药物obefazimod的开发，并推动公司实现卓越增长，在三年多时间里将公司市值从5亿美元提升至140亿美元。在加入Abivax之前，他于2020年至2023年担任CinCor Pharma的首席执行官，成功带领该公司被阿斯利康收购。

CinCor’s lead therapy was subsequently approved by the FDA as a first-in-class treatment for resistant hypertension. From 2018 to 2020, Mr. de Garidel served as CEO of Corvidia Therapeutics, overseeing its strategic growth and successful acquisition by Novo Nordisk. Earlier in his career, he served as CEO of Ipsen from 2010 to 2016, where he transformed the company into a leading global oncology player through the expansion of Somatuline and the landmark ex-U.S.

CinCor的核心疗法随后获得美国食品药品监督管理局（FDA）批准，成为首款用于治疗难治性高血压的同类首创药物。2018年至2020年，德·加里德尔先生担任Corvidia Therapeutics的首席执行官， overseeing其战略增长并成功促成该公司被诺和诺德收购。在其职业生涯早期，他于2010年至2016年担任Ipsen首席执行官，通过扩大Somatuline的市场覆盖以及达成具有里程碑意义的非美国地区交易，将公司转型为全球领先的肿瘤学企业。

licensing agreement for Cabometyx. Mr. de Garidel began his career at Eli Lilly and Company before spending 15 years at Amgen in senior international leadership roles. He has also served as Chairman of Ipsen since late 2010. .

Cabometyx的许可协议。德·加里德尔先生职业生涯始于礼来公司，随后在安进公司担任高级国际领导职务长达15年。自2010年末以来，他还一直担任益普生董事长。

“I’m thrilled to join Claris at such a pivotal moment in the company’s evolution,” said Mr. Brady, President and CEO of Claris. “The strong interest in CSB-001 reflects both its promise for patients and commercial potential. With the company financed through Phase 3 and the team in place to execute, we're ready to advance CSB-001 from a position of strength.

“在公司发展的这一关键阶段加入Claris，我感到非常兴奋。”Claris总裁兼首席执行官Brady先生表示。“市场对CSB-001的浓厚兴趣，既反映了该药物对患者的潜在获益，也体现了其商业潜力。公司已完成三期临床试验的资金筹措，执行团队也已就位，我们已准备好从有利地位推进CSB-001的研发进程。”

The prospect of significantly improving vision with a convenient eye drop is a tremendous advance, and I'm energized by the opportunity to take on a blinding disease like LSCD.”.

“通过一种便捷的眼药水显著改善视力前景广阔，这是一项巨大的进步；而有机会应对像角膜缘干细胞缺乏症（LSCD）这样致盲的疾病，让我充满动力。”

Marc de Garidel, Chairman of Claris Bio, added, “Claris is entering a defining period in its growth. In addition to welcoming Steve and Brian to Claris’ leadership team, I’d like to thank our founding CEO, Clarke Atwell, for his years of diligence in building the team and advancing the science underlying CSB-001, which allows us to approach this watershed moment with confidence.

Claris Bio董事长Marc de Garidel表示：“Claris正步入其成长过程中的一个关键时期。除了欢迎Steve和Brian加入Claris的领导团队外，我还要感谢我们的创始首席执行官Clarke Atwell多年来在组建团队以及推进CSB-001背后科学研究方面的勤勉付出，这使我们能够充满信心地迎接这一历史性时刻。”

We look forward to continuing our work to advance CSB-001 in patients with limbal stem cell deficiency and lead the company through its next phase as we approach commercialization.”.

我们期待继续推进CSB-001在角膜缘干细胞缺乏症患者中的研发工作，并引领公司迈向商业化阶段的下一步。

About LSCD and CSB-001

关于 LSCD 和 CSB-001

Limbal stem cell deficiency (LSCD) is a disease of the eye in which specialized stem cells that continuously replenish and repair the corneal surface are damaged or destroyed, leading to severe vision loss or blindness. CSB-001 (oremepermin alfa ophthalmic solution) contains recombinant human deleted hepatocyte growth factor (dHGF) as its active ingredient.

角膜缘干细胞缺乏症（LSCD）是一种眼部疾病，其特征是持续补充和修复角膜表面的特化干细胞受损或被破坏，从而导致严重的视力丧失或失明。CSB-001（oremepermin alfa 滴眼液）以重组人缺失型肝细胞生长因子（dHGF）为活性成分。

By promoting corneal epithelial regeneration while modulating inflammation and fibrosis, CSB-001 is intended to address the underlying pathophysiology of LSCD. Clinical data to date demonstrate substantial improvements in visual acuity in LSCD patients treated with CSB-001. If approved, CSB-001 has the potential to become the first pharmacologic treatment for LSCD, providing a reliable, accessible, and scalable non-surgical treatment option.

CSB-001旨在通过促进角膜上皮再生，同时调节炎症和纤维化，来解决LSCD的潜在病理生理机制。迄今为止的临床数据显示，接受CSB-001治疗的LSCD患者的视力有了显著改善。如果获得批准，CSB-001有望成为首个针对LSCD的药物治疗方案，提供一种可靠、易于获取且可扩展的非手术治疗选择。

Claris and Kringle Pharma, Inc., a company developing oremepermin alfa for non-ophthalmic indications, have a safety-data sharing collaboration that has enabled a more efficient development of oremepermin alfa..

Claris 与正在开发用于非眼科适应症的 oremepermin alfa 的 Kringle Pharma, Inc. 建立了安全数据共享合作关系，从而推动了 oremepermin alfa 更高效的开发。

Estimates indicate that at least 30,000 LSCD patients in the U.S. are actively being managed by an eye care professional, although given the lack of diagnosis, the number is likely larger.

据估计，美国至少有30,000名LSCD患者正在接受眼科专业人员的积极管理，尽管由于缺乏诊断，实际人数可能更多。

Ongoing and Planned CSB-001 Clinical Studies

正在进行及计划中的 CSB-001 临床研究

Proof-of-Concept Study.

概念验证研究。

An open-label clinical study evaluating the safety and efficacy of CSB-001 eyedrops in 63 LSCD subjects is ongoing. Subjects receive CSB-001 investigational eye drops in either one or both eyes over 20 weeks beginning on Day 0, or at Week 20 after a 20 week observational period. Completion of dosing is followed by an observational period.

一项评估CSB-001滴眼液在63名角膜缘干细胞缺乏症（LSCD）受试者中的安全性和有效性的开放标签临床研究正在进行中。受试者从第0天开始，或在经过20周的观察期后于第20周开始，在单眼或双眼接受CSB-001研究性滴眼液治疗，持续20周。给药结束后进入观察期。

More information can be found at clinicaltrials.gov (NCT06452316): .

更多信息可访问 clinicaltrials.gov（NCT06452316）：。

https://clinicaltrials.gov/study/NCT06452316

https://clinicaltrials.gov/study/NCT06452316

Pivotal Studies.

关键性研究。

In 1H 2027, Claris plans to initiate two pivotal studies evaluating the safety and efficacy of CSB-001 compared to vehicle in a total of approximately 400 LSCD subjects. The primary efficacy endpoint will be visual acuity supported by anatomical endpoints.

在2027年上半年，Claris计划启动两项关键研究，评估CSB-001与溶剂对照相比在约400名角膜缘干细胞缺乏症（LSCD）受试者中的安全性和有效性。主要疗效终点为视力，并由解剖学终点提供支持。

Non-Interventional Study.

非干预性研究。

To prepare for the planned pivotal studies, Claris is currently conducting a prospective non-interventional study in subjects with LSCD. This study will provide insights into the natural history of LSCD and characterize real-world LSCD management patterns, and identify and qualify investigative sites and potential study participants for the planned pivotal studies.

为筹备计划中的关键性研究，Claris 目前正在对角膜缘干细胞缺乏症（LSCD）患者开展一项前瞻性非干预性研究。该研究将提供对 LSCD 自然病程的洞察，描述真实世界中 LSCD 的管理模式，并为计划中的关键性研究筛选和确认研究中心及潜在受试者。

More information can be found at clinicaltrials.gov (NCT07636590): .

更多信息可在 clinicaltrials.gov（NCT07636590）上找到。

https://clinicaltrials.gov/study/NCT07636590

https://clinicaltrials.gov/study/NCT07636590

About Claris Bio

关于Claris Bio

Claris Biotherapeutics is a late-stage biopharmaceutical company dedicated to advancing transformative therapies for sight-threatening conditions where no or limited treatment options exist. With an initial focus on limbal stem cell deficiency (LSCD), a blinding disease, we are developing the first pharmacologic treatment with the potential to provide a reliable, accessible, and scalable non-surgical treatment option, while moving medical management beyond today's palliative care and towards meaningful improvements in vision and ocular surface health.

Claris Biotherapeutics 是一家处于后期阶段的生物制药公司，致力于推进针对威胁视力且现有治疗选择有限或匮乏的疾病的变革性疗法。我们最初聚焦于致盲性疾病——角膜缘干细胞缺乏症（LSCD），正在开发首个有望提供可靠、可及且可扩展的非手术治疗方案的药物治疗，从而将医疗管理从当前的姑息治疗提升至显著改善视力和眼表健康的新阶段。

Our near-term plan is to advance our lead therapeutic candidate, CSB-001 (oremepermin alfa ophthalmic solution), into LSCD pivotal studies in the first half of 2027, with a longer-term goal to become a leader in developing new therapies that improve vision and change patients’ lives. Foundational intellectual property for Claris was based on the scientific work of Drs.

我们的近期计划是推动我们的领先治疗候选药物CSB-001（oremepermin alfa眼科溶液）在2027年上半年进入LSCD关键性研究，长期目标是成为开发改善视力和改变患者生活的新疗法的领导者。Claris的基础知识产权基于博士们的科学研究工作。

Reza Dana, MD, MSc, MPH, and Sunil Chauhan, DVM, PhD., both from the Massachusetts Eye and Ear and the Harvard Medical School Department of Ophthalmology. To learn more, visit .

Reza Dana 医学博士、理学硕士、公共卫生硕士，以及 Sunil Chauhan 兽医学博士、哲学博士，均来自麻省眼耳医院和哈佛医学院眼科系。欲了解更多信息，请访问。

www.clarisbio.com

www.clarisbio.com

.

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Media Contact

媒体联系人

Jordyn Temperato

乔丁·坦佩拉托

LifeSci Communications

生命科学传播

jtemperato@lifescicomms.com

jtemperato@lifescicomms.com